The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Electro-nerve Stimulator B4/b400.
| Device ID | K851185 |
| 510k Number | K851185 |
| Device Name: | ELECTRO-NERVE STIMULATOR B4/B400 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 39636 Los Angeles, CA 90039 |
| Contact | Richard G Saxon |
| Correspondent | Richard G Saxon BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 39636 Los Angeles, CA 90039 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-01 |
| Decision Date | 1985-05-23 |